Herpes ZosterPhase 3NCT00535730

ZOSTAVAX™ Administered Concomitantly With PNEUMOVAX™ 23 (V211-012)(COMPLETED)

A Phase 3 study testing Zoster Vaccine, Live, (Oka-Merck), ZOSTAVAX™ and Pneumococcal Vaccine, Polyvalent (23-valent), PNEUMOVAX™ 23 in people with Herpes Zoster and Pneumococcal Infection, run by Merck Sharp & Dohme LLC.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to determine whether Zoster Vaccine Live and Pneumococcal Vaccine, polyvalent are as well tolerated and immunogenic when the vaccines are given together (in different body sites), as when they are given alone, in adults 60 years of age and older. Read more about this study

Who is it for?: Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for: Herpes Zoster, Pneumococcal Infection
What is being tested?: Zoster Vaccine, Live, (Oka-Merck), ZOSTAVAX™ and Pneumococcal Vaccine, Polyvalent (23-valent), PNEUMOVAX™ 23
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 473 participants
Where: No sites listed yet
Study dates: Jun 2007to Feb 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 60 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

60 years of age or older
Stable underlying conditions
Postmenopausal if female
Afebrile

Who cannot join

Previously vaccinated with either vaccine
Immune deficiency
History of allergy to components in either vaccine
Concomitant antiviral therapy

About this study

Official title: A Phase III Double-Blind, Randomized, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of ZOSTAVAX™ Administered Concomitantly Versus Nonconcomitantly With PNEUMOVAX™ 23 in Subjects 60 Years of Age and Older

Conditions: Herpes Zoster, Pneumococcal Infection
Being tested: Zoster Vaccine, Live, (Oka-Merck), ZOSTAVAX™, Comparator: placebo (concomitant-vaccine matched), Pneumococcal Vaccine, Polyvalent (23-valent), PNEUMOVAX™ 23
Medical subject headings: Herpes Zoster, Pneumococcal Infections

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Zoster Vaccine, Live, (Oka-Merck), ZOSTAVAX™Biological
Also called ZOSTAVAX™
0.65 mL injection Zoster Vaccine, Live, (Oka-Merck) over 4 week vaccination period
Comparator: placebo (concomitant-vaccine matched)Biological
Pneumococcal Vaccine, Polyvalent (23-valent) 0.5 mL Placebo injection over 4 week vaccination period.
Pneumococcal Vaccine, Polyvalent (23-valent), PNEUMOVAX™ 23Biological
Also called PNEUMOVAX™ 23
Pneumococcal Vaccine, Polyvalent (23-valent) 0.5 mL injection over 4 week vaccination period.

Study groups in NCT00535730
Study group	Role	What they receive
1	Placebo comparator	Placebo Comparator Receives: Biological: Zoster Vaccine, Live, (Oka-Merck), ZOSTAVAX™; Biological: Comparator: placebo (concomitant-vaccine matched)
2	Experimental	vaccine Receives: Biological: Zoster Vaccine, Live, (Oka-Merck), ZOSTAVAX™; Biological: Pneumococcal Vaccine, Polyvalent (23-valent), PNEUMOVAX™ 23

What is being measured

The primary outcome is the main question the study is designed to answer.

Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination
GMT of the VZV antibody responses at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 and those who receive ZOSTAVAX™ and PNEUMOVAX™ 23 nonconcomitantly.
*gpELISA = glycoprotein enzyme-linked immunosorbent assay
Measured: 4 weeks postvaccination
Geometric Mean Fold Rise (GMFR) of the Varicella-zoster Virus (VZV) Antibody Responses From Day 1 to 4 Weeks Postvaccination.
GMFR of the VZV antibody response from prevaccination to Week 4 postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23.
gpELISA = glycoprotein enzyme-linked immunosorbent assay.
Measured: Four weeks postvaccination
Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 3 Antibody Response at 4 Weeks Postvaccination.
GMT of the PnPs serotype 3 antibody response at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 and those who receive ZOSTAVAX™ and PNEUMOVAX™ 23 nonconcomitantly.
Measured: Four weeks postvaccination
Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 14 Antibody Response at 4 Weeks Postvaccination.
GMT of the PnPs serotype 14 antibody response at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 and those who receive ZOSTAVAX™ and PNEUMOVAX™ 23 nonconcomitantly.
Measured: Four weeks postvaccination
Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 19A Antibody Response at 4 Weeks Postvaccination.
GMT of the PnPs serotype 19A antibody response at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 and those who receive ZOSTAVAX™ and PNEUMOVAX™ 23 nonconcomitantly.
Measured: Four weeks postvaccination
Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 22F Antibody Response at 4 Weeks Postvaccination.
GMT of the PnPs serotype 22F antibody response at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 and those who receive ZOSTAVAX™ and PNEUMOVAX™ 23 nonconcomitantly.
Measured: Four weeks postvaccination

Secondary outcomes (1)

Safety and Tolerability of Both Vaccines When Administered Concomitantly.
All adverse events were analyzed including serious adverse events; injection-site adverse events; Vaccination Report Card prompted systemic adverse events, including varicella-like rashes or herpes zoster-like rashes; all other systemic adverse events.
Measured: Eight weeks postvaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2007Feb 2008

First posted26 Sep 2007 (estimated)
Study startJun 2007
Primary completionFeb 2008
Study completionFeb 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Herpes ZosterStudies of the same condition, open and under way.
More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 473 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00535730
Sponsor's protocol ID: V211-012
Other IDs: 2007_592
Status last verified: Mar 2017
First submitted: 21 Sep 2007
Last updated: 12 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php

Publications

MacIntyre CR, Egerton T, McCaughey M, Parrino J, Campbell BV, Su SC, Pagnoni MF, Stek JE, Xu J, Annunziato PW, Chan IS, Silber JL. Concomitant administration of zoster and pneumococcal vaccines in adults >/=60 years old. Hum Vaccin. 2010 Nov;6(11):894-902. doi: 10.4161/hv.6.11.12852. Epub 2010 Nov 1.
PubMed 20980796

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 1/2
Safety and Immunogenicity of Recombinant Varicella Zoster Virus Vaccine in People With HIV Who Have a CD4 Count Less Than 300 or Greater Than or Equal to 300 and a Healthy Control Population
Herpes Zoster
RecruitingPhase 4
Safety of the Herpes Zoster Subunit Vaccine in Lupus
Systemic Lupus Erythematosus
Active, not recruitingPhase 1/2
Clinical Trial of Recombinant Herpes Zoster Vaccine (CHO Cell) in Healthy Chinese Population Aged 40 Years and Older
Herpes Zoster, Herpes Zoster Vaccine
Active, not recruitingPhase 2
Safety and Immunogenicity of CVI-VZV-001 in Adults Aged 50 Years and Above
Herpes Zoster
Not yet recruitingPhase 1/2
Immunogenicity and Safety of SYS6052 in the Participants Aged 40 Years and Above
Herpes Zoster

All Herpes Zoster trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III Double-Blind, Randomized, Multicenter Study to Evaluate the Safety, Tolerability, and Immunogenicity of ZOSTAVAX™ Administered Concomitantly Versus Nonconcomitantly With PNEUMOVAX™ 23 in Subjects 60 Years of Age and Older
ClinicalTrials.gov ID: NCT00535730
Acronym / sponsor ID: V211-012
Conditions: Herpes Zoster, Pneumococcal Infection
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 473 participants (actual)
Lead sponsor: Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
Study start: Jun 2007
Primary completion: Feb 2008 (actual)
Study completion: Feb 2008 (actual)
First posted: 26 Sep 2007 (estimated)
Results: Posted 13 May 2009

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
1	Placebo comparator	Biological: Zoster Vaccine, Live, (Oka-Merck), ZOSTAVAX™, Biological: Comparator: placebo (concomitant-vaccine matched)Placebo Comparator
2	Experimental	Biological: Zoster Vaccine, Live, (Oka-Merck), ZOSTAVAX™, Biological: Pneumococcal Vaccine, Polyvalent (23-valent), PNEUMOVAX™ 23vaccine

Who may qualify

Ages: 60 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

60 years of age or older
Stable underlying conditions
Postmenopausal if female
Afebrile

Key exclusion criteria (4 listed)

Previously vaccinated with either vaccine
Immune deficiency
History of allergy to components in either vaccine
Concomitant antiviral therapy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Zoster Vaccine, Live, (Oka-Merck), ZOSTAVAX™Also: ZOSTAVAX™0.65 mL injection Zoster Vaccine, Live, (Oka-Merck) over 4 week vaccination period	Biological	1, 2
Comparator: placebo (concomitant-vaccine matched)Pneumococcal Vaccine, Polyvalent (23-valent) 0.5 mL Placebo injection over 4 week vaccination period.	Biological	1
Pneumococcal Vaccine, Polyvalent (23-valent), PNEUMOVAX™ 23Also: PNEUMOVAX™ 23Pneumococcal Vaccine, Polyvalent (23-valent) 0.5 mL injection over 4 week vaccination period.	Biological	2

Primary outcome

Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination
Time frame: 4 weeks postvaccination
GMT of the VZV antibody responses at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 and those who receive ZOSTAVAX™ and PNEUMOVAX™ 23 nonconcomitantly. *gpELISA = glycoprotein enzyme-linked immunosorbent assay
Geometric Mean Fold Rise (GMFR) of the Varicella-zoster Virus (VZV) Antibody Responses From Day 1 to 4 Weeks Postvaccination.
Time frame: Four weeks postvaccination
GMFR of the VZV antibody response from prevaccination to Week 4 postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23. gpELISA = glycoprotein enzyme-linked immunosorbent assay.
Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 3 Antibody Response at 4 Weeks Postvaccination.
Time frame: Four weeks postvaccination
GMT of the PnPs serotype 3 antibody response at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 and those who receive ZOSTAVAX™ and PNEUMOVAX™ 23 nonconcomitantly.
Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 14 Antibody Response at 4 Weeks Postvaccination.
Time frame: Four weeks postvaccination
GMT of the PnPs serotype 14 antibody response at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 and those who receive ZOSTAVAX™ and PNEUMOVAX™ 23 nonconcomitantly.
Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 19A Antibody Response at 4 Weeks Postvaccination.
Time frame: Four weeks postvaccination
GMT of the PnPs serotype 19A antibody response at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 and those who receive ZOSTAVAX™ and PNEUMOVAX™ 23 nonconcomitantly.
Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 22F Antibody Response at 4 Weeks Postvaccination.
Time frame: Four weeks postvaccination
GMT of the PnPs serotype 22F antibody response at 4 weeks postvaccination in subjects who receive ZOSTAVAX™ concomitantly with PNEUMOVAX™ 23 and those who receive ZOSTAVAX™ and PNEUMOVAX™ 23 nonconcomitantly.

1 secondary outcome

Safety and Tolerability of Both Vaccines When Administered Concomitantly.
Time frame: Eight weeks postvaccination

Results and safety

Results posted to the registry on 13 May 2009, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Nonconcomitant Group	236	234
Concomitant Group	237	230

Primary outcome: Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination

Time frame: 4 weeks postvaccination. Geometric mean (95% Confidence Interval). Unit: gpELISA units*/mL

Measure	Nonconcomitant Group n = 225	Concomitant Group n = 217
Value	448.5 (400.3 to 502.4)	371.6 (328.7 to 420.0)

Nonconcomitant Group vs Concomitant Group: p = 0.244, longitudinal regression model

Population analysed: Analysis was per protocol. The following protocol violations resulted in exclusion of subjects from analysis: receipt of prohibited medications; vaccine temperature compromised prior to administration; excluded medical condition; samples collected outside of Statistical Analysis Plan specified time window; exposure to herpes zoster (HZ) or VZV.

Primary outcome: Geometric Mean Fold Rise (GMFR) of the Varicella-zoster Virus (VZV) Antibody Responses From Day 1 to 4 Weeks Postvaccination.

Time frame: Four weeks postvaccination. Geometric mean (95% Confidence Interval). Unit: gpELISA units/mL

Measure	Concomitant Group n = 217
Value	1.9 (1.7 to 2.1)

Concomitant Group: p <0.001, t-test, 1 sided

Primary outcome: Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 3 Antibody Response at 4 Weeks Postvaccination.

Time frame: Four weeks postvaccination. Geometric mean (95% Confidence Interval). Unit: micrograms/mL

Measure	Nonconcomitant Group n = 228	Concomitant Group n = 219
Value	1.2 (1.1 to 1.4)	1.1 (1.0 to 1.2)

Nonconcomitant Group vs Concomitant Group: p <0.001, longitudinal regression model

Population analysed: Analysis was per protocol. The following protocol violations resulted in exclusion of subjects from analysis: prior receipt of a pneumococcal vaccine; receipt of prohibited medications; vaccine temperature compromised prior to administration; excluded medical condition; samples collected outside of Statistical Analysis Plan specified time window.

Primary outcome: Geometric Mean Titer (GMT) of the Pneumococcal Polysaccharide (PnPs) Serotype 14 Antibody Response at 4 Weeks Postvaccination.

Time frame: Four weeks postvaccination. Geometric mean (95% Confidence Interval). Unit: micrograms/mL

Measure	Nonconcomitant Group n = 228	Concomitant Group n = 219
Value	26.5 (22.9 to 30.8)	25.7 (21.8 to 30.3)

Nonconcomitant Group vs Concomitant Group: p <0.001, longitudinal regression model

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nonconcomitant Group	4 of ?	154 of ?	Not reported
Concomitant Group	2 of ?	143 of ?	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 20980796MacIntyre CR, Egerton T, McCaughey M, Parrino J, Campbell BV, Su SC, Pagnoni MF, Stek JE, Xu J, Annunziato PW, Chan IS, Silber JL. Concomitant administration of zoster and pneumococcal vaccines in adults >/=60 years old. Hum Vaccin. 2010 Nov;6(11):894-902. doi: 10.4161/hv.6.11.12852. Epub 2010 Nov 1.
Individual participant dataSharing planned: Yes. http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php

Related trials for Herpes Zoster

RecruitingPhase 1/2
Safety and Immunogenicity of Recombinant Varicella Zoster Virus Vaccine in People With HIV Who Have a CD4 Count Less Than 300 or Greater Than or Equal to 300 and a Healthy Control Population
Herpes Zoster
RecruitingPhase 4
Safety of the Herpes Zoster Subunit Vaccine in Lupus
Systemic Lupus Erythematosus
Active, not recruitingPhase 1/2
Clinical Trial of Recombinant Herpes Zoster Vaccine (CHO Cell) in Healthy Chinese Population Aged 40 Years and Older
Herpes Zoster, Herpes Zoster Vaccine
Active, not recruitingPhase 2
Safety and Immunogenicity of CVI-VZV-001 in Adults Aged 50 Years and Above
Herpes Zoster
Not yet recruitingPhase 1/2
Immunogenicity and Safety of SYS6052 in the Participants Aged 40 Years and Above
Herpes Zoster

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Medical Monitor study director

Merck Sharp & Dohme LLC

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 May 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Geometric Mean Titer (GMT) of Varicella-zoster Virus (VZV) Antibody Responses at 4 Weeks Postvaccination (time frame: 4 weeks postvaccination). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00535730, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2017.